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The Indian Medicines Pharmaceutical Corporation Ltd has applied for “WHO-GMP/COPP certification for 18 Ayurvedic products recently.
WHO-GMP/COPP Certification
- The certificate of pharmaceutical product (CPP or CoPP) is a certificate issued in the format recommended by the World Health Organization (WHO).
- The CPP is aimed at diminishing the risks inherent in pharmaceutical production.
- The application for grant of WHO GMP Certificate of Pharmaceutical Product shall be made to respective zonal/sub zonal officers as per the requirement.
- The certificate recipient authority has in its national medicine legislation or guidelines a requirement for the submission of a CPP for products being imported into the country as a support to ensure the quality of the product being imported.
- The COPP is issued by zonal/sub zonal officers on behalf of Drugs Controller General (India) after inspection and satisfactory clearance by Central Drugs Standard Control Organisation(CDSCO) officers as per WHO – GMP guidelines.
- The WHO-GMP certificate is required for pharmaceutical companies to sell medicines in most global markets.
- It is valid for 3 years from the date of issue and companies can apply for renewal after that.
- The certificate helps the regulator ensure that drugs are consistently produced and are quality controlled before they leave the country.
- GMP stands for Good Manufacturing Practice which is a system for ensuring that products are consistently produced and controlled, according to quality standards.
- In 1969, when the World Health Assembly recommended the first version of the WHO Certification Scheme on the quality of pharmaceutical products moving in the global market, it accepted the WHO GMP as an integral part of the Scheme.
- The WHO GMP continues to be used as a basis for the WHO Certification Scheme and prequalification of vaccines for procurement by UN agencies.
The Indian Medicines Pharmaceutical Corporation Ltd (IMPCL)
- It is a CPSE under the administrative control of Ministry of AYUSH, Govt. of India.
- It was established on 12th July 1978 with the prime objective to manufacture and market the Genuine and Efficacious Indian System of Medicines.
- The purpose of establishment of IMPCL is to fulfill the need of CGHS, CCRAS, CCRUM, ESIC, Central/ State government institution(s) for the continuous supply of Ayurvedic & Unani Medicines as per their programme requirements.
- IMPCL is located in the valley of Uttarakhand Hills in the corridor of National Jim Corbett Park
- It is the only Central Public Sector Enterprise (CPSE) in the field of manufacturing Ayurvedic and Unani Medicines.
- IMPCL is a joint venture of Government of India (98.11% Equity Shares) and Uttarakhand State Government through KMVNL (1.89% Equity Shares). IMPCL is conferred Mini Ratna status by the Govt. of India.
Source: PIB
